FDA directs Palladone withdrawal

The pain management drug can trigger fatal results if taken with alcohol finds FDA. Purdue Pharma agrees to withdraw drug.

BY OUR PHARMA CORRESPONDENT

July 15, 2005: Purdue Pharma's Palladone drug may soon out of the market. After the US FDA obtained information that the drug can be dangerous and potentially fatal when used along with alcohol, the US drug regulatory
body has asked the company to withdraw the extended release drug from the market.

A very potent narcotic, Palldone is a once-a-day pain management medicine. New information has shown that the when taken along with alcohol, the drug's extended release mechanism is hampered, leading to dose dumping. In dose-dumping, the active ingirdient of the drug is rapidly released from a product into the blood stream, creating medical complications. Even at low doses, such Palladone dose dumping can have serious consequences. In some patients, the risk is much higher, and can be fatal.

Due to this potential health risk, the FDA has directed Purdue Pharma, to withdraw Palladone. All sales and marketing of Palladone have been suspended, pending
further discussions and studies.

The existing labeling for Palladone, which was approved in 2004 September, 2004, has the standard opioid warning against using alcohol along with the drug. However, the FDA believes that the
safety risk is quite high in this case, and such a labelling will not suffice. Those who are taking Palladone currently have been advised by FDA to consult their doctors for for other treatments.

Said Dr Steven Galson, FDA Acting Director of the Center
for Drug Evaluation and Research: "All powerful pain management drugs have serious risks if used incorrectly, but the current formulation of Palladone presents an unacceptably high level of patient risk. Although we have not received reports of serious problems, this product has so far been used in a relatively small number of patients. We are concerned that as more patients take this drug, safety problems will arise since even having one alcoholic drink could have fatal implications."